BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1232158 · Received November 4, 2008

    Report

    Report Number
    2939301-2008-02942
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Report Date
    October 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS HAVING THE FOLLOWING UNRESOLVED POWER RELATED ISSUE: ONETOUCH ULTRALINK METER DOES NOT TURN ON. AS A RESULT, THE PT CLAIMED THAT NO CHANGES WERE MADE TOWARDS HER DIABETES ROUTINE. THE PT REPORTEDLY DEVELOPED SYMPTOMS OF "THIRSTY" BEFORE AND DURING THE ALLEGED ISSUE; THEREFORE, THE SUBJECT METER DID NOT CAUSE THE PT TO EXPERIENCE THE ALLEGED SYMPTOMS. THIS WAS NOT A BRAND NEW OUT OF BOX PRODUCT AND THE CONDITION OF THE BATTERY WAS GOOD. THE PT'S PRODUCTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2833532

    Patients

    Seq Age Sex Outcome Treatment
    1